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Proton Beam Therapy

Proton Beam Radiation for Wilms Tumor

Phase 2

Recruiting

Led By Matthew J Krasin, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior radiation therapy is not allowed if directed at the abdomen. Emergent RT to other sites of disease is acceptable

Only prior therapy with the initial chemotherapy regimen defined in section 5.1 and Appendix III are allowed for patients that are treated with neoadjuvant chemotherapy. These patients may change to an alternate regime based on response or biologic features and noted in section 5.1. Prior biopsy or surgery is allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen

Awards & highlights

Study Summary

This trial is for patients with Wilms Tumor cancer who will have proton beam radiation to a conformal reduced target volume in the flank. The objective is to allow normal flank growth compared to the contralateral untreated side and non-irradiated patients.

Who is the study for?

This trial is for patients with a newly diagnosed Wilms Tumor, who haven't had abdominal radiation before. It's open to those who've only had specific initial chemotherapy or surgery, and are within certain time frames post-surgery. Pregnant women can't participate, nor can those unwilling to consent or previously treated with radiation in the areas targeted by this study.Check my eligibility

What is being tested?

The trial tests if proton beam radiation can be delivered more precisely to reduce side effects and allow normal growth of non-cancerous tissue compared to traditional methods. It also explores how well it spares healthy organs during whole abdomen therapy and assesses its impact on physical performance versus photon therapy.See study design

What are the potential side effects?

Potential side effects may include damage to nearby organs not being treated (like kidneys, liver), changes in blood counts, fatigue from treatment sessions, skin reactions at the site of radiation delivery, and possible late-term impacts on organ function which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had radiation therapy targeted at my abdomen.

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I have followed the specific chemotherapy plan outlined for my condition and may switch based on my response.

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I am a woman who can have children and have a negative pregnancy test.

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My cancer is at stage I or II, and I am eligible for surgery and biological treatment.

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I am diagnosed with Wilms tumor.

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I will start radiation therapy within 28 days after my surgery, aiming for day 21.

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My Wilms tumor was surgically removed and had a favorable type.

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My tumor has a type of cell that disqualifies me from the treatment part of the study.

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I am at the initial stages of being diagnosed with Wilms tumor.

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I am mostly able to care for myself and carry out daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen

This trial's timeline: 3 weeks for screening, Varies for treatment, and half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Half circumference at 10 year

Half circumference at 3 year

Half circumference at 5 year

+1 more

Secondary outcome measures

Local control rate in a partially radiated kidney

Trial Design

3Treatment groups

Active Control

Group I: Stage V Adjuvant RT:Active Control3 Interventions

Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT

Group II: Favorable Histology Stage I & II and FH Stage III/IVActive Control1 Intervention

Favorable Histology Stage I & II and FH Stage III/IV Delayed Local Control with clear surgical margins and pathologically negative lymph nodes. Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy.

Group III: Stage III & IV Adjuvant RT and Stage VActive Control3 Interventions

Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,518 Total Patients Enrolled

7 Trials studying Wilms Tumor

3,305 Patients Enrolled for Wilms Tumor

Matthew J Krasin, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Proton Beam Radiation (PBRT) (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04968990 — Phase 2

Wilms Tumor Research Study Groups: Stage V Adjuvant RT:, Favorable Histology Stage I & II and FH Stage III/IV, Stage III & IV Adjuvant RT and Stage V

Wilms Tumor Clinical Trial 2023: Proton Beam Radiation (PBRT) Highlights & Side Effects. Trial Name: NCT04968990 — Phase 2

Proton Beam Radiation (PBRT) (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04968990 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this research program?

"According to the data on clinicaltrials.gov, this trial is currently open for recruitment and has been since its initial post date of August 19th 2021. The information was last updated on September 1st 2022."

Answered by AI

What is the aggregate figure of participants for this research?

"Verified. The clinicaltrials.gov website confirms that this trial, which was first posted on August 19th 2021, is actively recruiting participants. 95 individuals are required to be recruited from a single medical site."

Answered by AI

What potential repercussions could patients encounter when undergoing Favorable Histology Stages I & II and FH Stage III/IV?

"Due to its Phase 2 status, our team at Power has assigned Favorable Histology Stage I & II and FH Stage III/IV a safety rating of 2 on the scale from 1 – 3. This is based off existing evidence that suggests their level of security but lack of data verifying efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation

2021. "Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04968990.